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Merck's Fosamax Goes On Trial

Posted by Priti Patnaik

Starting Tuesday, pharma giant Merck & Co., Inc., faces the first trial over its osteoporosis drug Fosamax. More than 900 such lawsuits have been filed by more than 1,200 plaintiffs in state and federal courts. The suits claim that doctors were not warned that the drug may hamper blood flow to the jaw, causing jawbone-tissue death--osteonecrosis of the jaw, or ONJ. In some cases, ONJ leads to partial removal of the jaw.

Plaintiff Shirley Boles, 71, is represented by partner Timothy O'Brien and associates Meghan Tans and Ned McWilliams of Levin, Papantonio, Thomas, Mitchell, Echsner & Proctor. Michelle Parfitt and James Green at Ashcraft & Gerel are also working on the case.

Merck's trial team includes Paul Strain of Venable in Baltimore and Christy Jones of Butler, Snow, O'Mara, Steves & Cannada. Both represented Merck in the marathon Vioxx litigation. The company declined to name the other attorneys working on the case, saying that the information was part of its litigation strategy.

Judge John Keenan will preside over the trial in federal district court in Manhattan.

"[Boles] now suffers from stage III of ONJ and will continue to do so for the rest of her life,” says plaintiffs counsel O'Brien. “As a result, the damages sought at the time of closing argument will be significant." The plaintiffs allege that the company did not adhere to Food and Drug Administration labeling requirements.

Merck has said that evidence will show that Fosamax was not the cause of Boles's condition.

Venable's Strain said in a statement: "Unfortunately, Ms. Boles had medical problems that cause people to develop jaw problems, regardless of whether they were taking Fosamax." She had significant periodontal disease and a history of smoking up to a pack of cigarettes a day which can result in poor wound healing, Strain said.

O'Brien maintains that the company does not have evidence that smoking causes osteonecrosis of the jaw. "But Merck was on notice that Fosamax causes jaw bone damage prior to 2003," he says.

Last week, Judge Keenan ruled out the possibility of punitive damages in the Boles trial. But the plaintiff's side points out that Judge Keenan's ruling is specific to this one case, based on the client's date of injury. Plaintiffs in other cases against Merck can still seek punitive damages.